Ethylene Oxide - Avoiding Pitfalls During Sterilisation Cycle Development

Ethylene Oxide (EO) Gas is commonly used in the sterilisation of medical devices due to its compatibility with a variety of materials. Understanding what factors are impactful to the validation process will help to avoid pitfalls during the pathway to product launch. The increasing amount of information documents such as ISO 11135 and ISO 10993-7, lay the foundations for development, validation, and routine control. Sterilising a medical device is one way to ensure patient safety, however, it’s important to consider the residual levels left behind from Ethylene Oxide (EO) Gas that make it difficult to predict when a medical device will be safe for release to the public. Another item that must be considered is the microbial load, which impacts the cycle development.

During this webinar, our experts will provide insights into Ethylene Oxide (EO) Sterilisation, such as:

• An introduction to EO Sterilisation: Why is it important and when is it appropriate for a medical device?
• Factors impacting EO Sterilisation, including effectiveness, release, and dwell/aeration times.
• Validation of EO Sterilisation from product development through regulatory submission.
• Types of EO Residuals, testing methods, and ISO 10993-7 considerations.
• An overview of sterility testing, including regulatory requirements and methods.